Abstract
In sub-Saharan Africa, HIV incidence and prevalence remain disproportionately high among women. Vaginal rings (VRs) have been
formulated for the delivery of antiretroviral-based microbicides, and their favorable safety and tolerability profiles reported
in clinical studies. Although the concept of drug release through a VR has existed since 1970, and VRs have been marketed
since 1992 for contraceptive or hormone replacement purposes, VR use as a microbicide delivery system is a novel application.
This is the first study to evaluate VR adherence among African women in the context of its potential use as an HIV prevention
method, to examine predictors of adherence, and to describe clinical or contextual reasons for VR removals or nonadherence.
This was a randomized trial of the safety and acceptability of a placebo VR worn for 12 weeks in 170 HIV-negative, African
women aged 18–35 in four clinic sites in South Africa and Tanzania. The findings suggest that adherence to VR use in the context
of HIV prevention trials in these communities should be high, thereby enabling more accurate assessment of an active microbicide
safety and efficacy.
formulated for the delivery of antiretroviral-based microbicides, and their favorable safety and tolerability profiles reported
in clinical studies. Although the concept of drug release through a VR has existed since 1970, and VRs have been marketed
since 1992 for contraceptive or hormone replacement purposes, VR use as a microbicide delivery system is a novel application.
This is the first study to evaluate VR adherence among African women in the context of its potential use as an HIV prevention
method, to examine predictors of adherence, and to describe clinical or contextual reasons for VR removals or nonadherence.
This was a randomized trial of the safety and acceptability of a placebo VR worn for 12 weeks in 170 HIV-negative, African
women aged 18–35 in four clinic sites in South Africa and Tanzania. The findings suggest that adherence to VR use in the context
of HIV prevention trials in these communities should be high, thereby enabling more accurate assessment of an active microbicide
safety and efficacy.
- Content Type Journal Article
- Category Original Paper
- Pages 1-12
- DOI 10.1007/s10461-012-0248-4
- Authors
- Elizabeth T. Montgomery, Women’s Global Health Imperative, RTI International (Research Triangle Institute), 114 Sansome Street, Suite 500, San Francisco, CA 94104-3812, USA
- A. van der Straten, Women’s Global Health Imperative, RTI International (Research Triangle Institute), 114 Sansome Street, Suite 500, San Francisco, CA 94104-3812, USA
- H. Cheng, Women’s Global Health Imperative, RTI International (Research Triangle Institute), 114 Sansome Street, Suite 500, San Francisco, CA 94104-3812, USA
- L. Wegner, Women’s Global Health Imperative, RTI International (Research Triangle Institute), 114 Sansome Street, Suite 500, San Francisco, CA 94104-3812, USA
- G. Masenga, Kiliminjaro Christian Medical Center, Moshi, Tanzania
- C. von Mollendorf, Wits Reproductive Health and HIV Research Institute, Johannesburg, South Africa
- L. Bekker, University of Cape Town and Desmond Tutu HIV Foundation, Cape Town, South Africa
- S. Ganesh, South African Medical Research Council, Durban, South Africa
- K. Young, International Partnership for Microbicides, Paarl, South Africa
- J. Romano, NWJ Group, LLC, Wayne, PA, USA
- A. Nel, International Partnership for Microbicides, Paarl, South Africa
- C. Woodsong, International Partnership for Microbicides, Paarl, South Africa
- Journal AIDS and Behavior
- Online ISSN 1573-3254
- Print ISSN 1090-7165